Status and phase
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About
RATIONALE: BI 2536 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of BI 2536 in treating patients with refractory or relapsed advanced non-Hodgkin's lymphoma.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation, open-label, uncontrolled, multicenter study.
Patients receive BI 2536 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BI 2536 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity during the first treatment course. Up to 24 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically until disease progression or initiation of another cancer treatment.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed advanced aggressive non-Hodgkin's lymphoma (NHL), including any of the following subtypes:
B-cell NHL, including any of the following subtypes:
T-cell NHL, including any of the following subtypes:
De novo or transformed disease
Refractory (i.e., disease not amenable to standard therapy) or relapsed disease, as evidenced by 1 of the following:
At least 1 bidimensionally measurable lesion ≥ 1.5 cm by CT scan, MRI, x-ray, or clinical examination
No active CNS lymphoma
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No prior radiotherapy to the only site of measurable disease unless there is documented disease progression after completion of radiotherapy
More than 8 weeks since prior and no concurrent systemic radioimmunotherapy
More than 3 weeks since prior and no concurrent radiotherapy
Other
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Data sourced from clinicaltrials.gov
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